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Serving leading biopharmaceutical companies globally:

Fish and Richardson
AstraZeneca
Covington
UBS
Cipla
Chubb
Citi
Teva
Federal Trade Commission
Express Scripts

Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021127

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NDA 021127 describes OPTIVAR, which is a drug marketed by Mylan Speciality Lp and is included in one NDA. It is available from one supplier. Additional details are available on the OPTIVAR profile page.

The generic ingredient in OPTIVAR is azelastine hydrochloride. There are twelve drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride profile page.
Summary for 021127
Tradename:OPTIVAR
Applicant:Mylan Speciality Lp
Ingredient:azelastine hydrochloride
Patents:0
Therapeutic Class:Ophthalmic Agents
Respiratory Tract Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 021127
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OPTIVAR azelastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 021127 NDA AUTHORIZED GENERIC Wallace Pharmaceuticals Inc. 51525-7815 E 51525-7815-6

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION/DROPS;OPHTHALMICStrength0.05%
Approval Date:May 22, 2000TE:RLD:Yes

Expired US Patents for NDA 021127

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Speciality Lp OPTIVAR azelastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 021127-001 May 22, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Speciality Lp OPTIVAR azelastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 021127-001 May 22, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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UBS
US Army
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